Cleared Traditional

K950771 - DISPOSABLE ADHESIVE FACE MASK
(FDA 510(k) Clearance)

K950771 · Advanced Warming Systems, Inc. · Anesthesiology

Mar 1995

Decision

382d

Days

Class 1

Risk

K950771 is an FDA 510(k) clearance for the DISPOSABLE ADHESIVE FACE MASK, a Mask, Gas, Anesthetic (Class I — General Controls, product code BSJ), submitted by Advanced Warming Systems, Inc. (Lubbock, US). The FDA issued a Cleared decision on March 10, 1995, 382 days after receiving the submission on February 21, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5550.

Submission Details

510(k) Number	K950771 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 1994
Decision Date	March 10, 1995
Days to Decision	382 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement